Memorial Hospital East

Researchers are evaluating the addition of pembrolizumab immunotherapy to standard chemotherapy for patients with stage IIA, IIB, IIIA, or IIIB non-small cell lung cancer NSCLC that has been completely removed by surgery. This phase III trial aims to compare disease-free survival and overall survival among different treatment approaches, including chemotherapy alone, chemotherapy followed by pembrolizumab, and chemotherapy combined with pembrolizumab. The study also assesses quality of life and adverse event rates in these patient groups. Participants are randomly assigned to one of three groups. One group receives only chemotherapy with observation afterward. The other two groups receive chemotherapy followed by pembrolizumab or chemotherapy combined with pembrolizumab. Chemotherapy involves one of four platinum doublet regimens administered every 21 days for four cycles, depending on the physicians choice. Pembrolizumab is given intravenously over 25-40 minutes, either after chemotherapy or alongside it, repeated every 21 days or every 6 weeks for multiple cycles. Patients also undergo heart ultrasound, MRI, CT scans, and blood sample collections as part of the study. During the trial, participants have regular medical assessments including imaging and blood tests to monitor their health. Follow-up visits occur 6 weeks after treatment, then every 3 months for 2 years, every 6 months for years 2-4, and annually up to 10 years from randomization. Researchers measure disease-free survival as the main outcome, tracking the time until cancer recurrence or death. They also evaluate overall survival, side effects, drug tolerability, and patient-reported quality of life over time.

Researchers are investigating targeted therapies directed by genetic testing for patients with locally advanced or advanced solid tumors that have spread or progressed after standard treatments. This Phase 2 screening trial, called ComboMATCH, aims to match patients to specific combination treatments based on genetic mutations found in their tumor cells. The study seeks to improve treatment planning by using genetic information to guide therapy choices. Patients undergo tumor genetic screening using previously collected samples or a new biopsy if eligible and aged 18 or older. Based on their tumors genetic profile, patients are assigned to one of multiple treatment subprotocols involving different drug combinations. Treatments include oral, intravenous, and intramuscular drugs such as selumetinib, olaparib, fulvestrant, binimetinib, and others. Treatment cycles generally repeat every 28 days until disease progression or unacceptable toxicity. Patients may also undergo biopsies, blood collection, imaging scans CT, MRI, PET, echocardiograms, and bone marrow procedures as part of the study. Throughout the trial, participants have regular assessments including tumor biopsies, blood draws, imaging tests, and heart function monitoring. These evaluations occur during screening, treatment, and follow-up periods. Researchers measure patient enrollment, assignment to treatment arms, and treatment outcomes over up to 8 years. Safety is monitored via clinical evaluations and diagnostic tests. This comprehensive approach aims to evaluate responses to targeted therapies guided by tumor genetics for advanced solid tumors.

Researchers are evaluating whether adding paclitaxel chemotherapy directly into the abdominal cavity, alongside chemotherapy given through a vein, can better control the spread or growth of gastric cancer that has spread to the abdominal cavity. The study compares this combination approach to the usual chemotherapy treatment for this cancer type. The trial includes a surgical procedure called diagnostic laparoscopy to examine the abdomen and determine the appropriate treatment group for each participant. Participants will undergo diagnostic laparoscopy under general anesthesia, during which they will be randomly assigned to one of two groups. One group receives standard chemotherapy through the vein alone, while the other group receives the same chemotherapy plus paclitaxel delivered directly into the abdomen via an intraperitoneal port placed during surgery. Treatment cycles occur every 21 days for four cycles, with assessments after three months to decide whether to continue treatment or consider surgery to remove the cancer if possible. During the study, participants will have regular imaging scans such as CT or MRI to monitor disease status and blood samples collected periodically. After completing treatment, follow-up visits occur every three months for the first two years and then every six months up to five years to watch for side effects and cancer progression. Researchers will measure progression-free survival and overall survival to evaluate the treatments, along with monitoring adverse events related to the therapy.

Researchers are evaluating a master screening protocol called Lung-MAP for patients with previously treated non-small cell lung cancer. This phase IIIII trial aims to develop a genomic screening method for large cancer populations and assign participants to appropriate sub-studies based on specific cancer biomarkers. The goal is to compare new targeted therapies designed to block cancer growth or spread with standard care, including sub-studies for patients not eligible for biomarker-driven treatments. The study involves screening patient specimens to determine eligibility for various biomarker-driven or non-matched sub-studies within the Lung-MAP umbrella protocol. This is a screening study without direct interventions instead, patients are assigned to different treatment sub-studies, each operating independently. The protocol also includes an optional ancillary study evaluating attitudes about the return of somatic mutation findings suggestive of germline mutations. Participants provide tumor tissue for biomarker testing, including molecular profiling and PD-L1 analysis, and may submit fresh biopsies and blood samples for circulating tumor DNA testing. Researchers will monitor screening success rates up to three years and collect patient and physician feedback on genetic findings. Participation involves signing informed consent, providing smoking history, and possibly completing surveys. The study duration and assessments vary depending on sub-study assignment and patient progression.

Researchers are evaluating the combination of durvalumab, gemcitabine, and cisplatin given before surgery to treat patients with high-risk liver cancer called resectable intrahepatic cholangiocarcinoma. This phase II study aims to see how well patients complete this pre-surgery therapy and proceed to surgical removal of the tumor. The study also investigates tumor response, survival rates, and the safety and feasibility of the treatment approach. Participants receive durvalumab intravenously on day 1, with gemcitabine and cisplatin given intravenously on days 1 and 8, repeated every 21 days for 4 cycles before surgery. After surgery, patients may continue the same regimen for up to 4 more cycles if disease progression or unacceptable side effects do not occur. During the study, patients undergo CT and MRI scans, blood sample collection, and tissue biopsies at screening and during treatment. Throughout the study, participants are closely monitored with imaging and laboratory tests to evaluate tumor response and detect side effects. After completing treatment, patients have follow-up visits every 3 months for 2 years, then every 6 months for 5 years, and yearly afterward to assess survival and cancer recurrence. The main outcome measured is the proportion of patients who complete the pre-surgery therapy and surgery, with additional measures including pathological response, margin status after surgery, radiological response, overall and relapse-free survival, and adverse events.

Researchers are evaluating the effect of adding the drug tivozanib to the immunotherapy pembrolizumab compared to pembrolizumab alone in patients with high-risk renal cell carcinoma RCC. The study aims to determine whether this combination improves disease-free survival and overall survival. This phase III trial also assesses side effects, quality of life, and collects specimens for future research in patients who have undergone surgery to remove all known kidney cancer sites. In this study, participants are randomly assigned to one of two groups. One group receives pembrolizumab intravenously on specific days of each 12-week cycle for up to 4 cycles. The other group receives the same pembrolizumab schedule combined with oral tivozanib taken daily on specific days within the 12-week cycle for up to 6 months. Throughout the trial, participants undergo blood samples, MRI or CT scans, and may have tissue biopsies. After treatment, patients are followed regularly for up to 10 years to monitor outcomes. Participants will have scheduled visits during treatment cycles and follow-up visits every 4 months for 2 years, then every 6 months for 3 years, and annually for 5 more years. The research team measures disease recurrence or death disease-free survival as the main outcome, along with overall survival, side effects, treatment tolerance, and quality of life. Safety monitoring and quality of life assessments are included to evaluate the impact of the treatments over the long term.

Researchers are investigating whether adding the drug Docetaxel to the usual hormone treatments, Androgen Deprivation Therapy ADT and Androgen-Receptor Pathway Inhibitor ARPI, can better control metastatic castration sensitive prostate cancer in men who have not responded optimally to initial hormone therapy. This phase III, international, open-label, randomized trial seeks to compare the effectiveness of this combined approach against the standard hormone therapy alone. Participants will be randomly assigned to receive either the standard hormone therapy with ADT plus ARPI or the same hormone therapy combined with Docetaxel chemotherapy. The trial focuses on men with metastatic prostate cancer who continue to have elevated PSA levels after 6 to 12 months of hormone-targeting treatment. Treatments are administered according to physician choice and assignment, and the study evaluates outcomes over a long period. During the trial, participants will be closely monitored with assessments including PSA levels and clinical progression over 39 months. Researchers will measure overall survival as the primary outcome, along with secondary outcomes such as PSA progression, PSA response, PSA kinetics, and progression-free survival. Participants must be accessible for treatment and follow-up to allow for complete documentation of treatment effects and adverse events throughout the study duration.

Researchers are evaluating the combination of immunotherapy drugs nivolumab and ipilimumab with the immunosuppressants sirolimus and prednisone to treat advanced skin cancers that cannot be removed by surgery or have spread in patients who have received kidney transplants. This phase II trial aims to assess whether this combination can control cancer while preserving kidney transplant health. The study also explores immune system changes, tumor environment effects, and markers related to transplant rejection. Participants take sirolimus and prednisone orally daily starting one week before immunotherapy begins. Nivolumab and ipilimumab are given intravenously in the first two cycles at specific days, followed by tumor assessments at six weeks. Those showing stable disease or better continue nivolumab every four weeks for up to 24 cycles unless disease worsens or side effects occur. If progression happens, participants may receive a short course of nivolumab plus ipilimumab every three weeks, followed by nivolumab alone if response is achieved. Imaging, biopsies, and blood tests are performed throughout the study to monitor cancer and transplant status. Participants undergo MRI scans during screening and may have biopsies of tumors or kidneys if needed. CT scans and blood samples are collected regularly to track disease and immune responses. After treatment ends, follow-up visits occur every 12 weeks for one year, then every 16 weeks in the second year, and every 20 weeks up to five years. Researchers measure cancer response without kidney transplant loss at 14 weeks as the main outcome, as well as longer-term survival, transplant rejection rates, and immune changes over time.

Researchers are evaluating targeted treatments for metastatic prostate cancer by using genetic testing to guide therapy choices. This phase II trial studies whether identifying DNA and RNA abnormalities in cancer tissue can help assign patients to specific treatments including valemetostat tosylate, carboplatin with cabazitaxel, or physician-chosen therapies such as cabazitaxel, abiraterone acetate with prednisone, enzalutamide, or lutetium Lu 177 vipivotide tetraxetan. The study aims to assess tumor response, safety, progression-free survival, overall survival, and patient-reported outcomes. Patients undergo genetic testing on previously collected tissue samples to determine their treatment group. In Arm A, patients receive valemetostat tosylate orally once daily in 28-day cycles. Arm B patients receive carboplatin and cabazitaxel intravenously every 21 days. Arm C patients receive one of several treatments chosen by their physician, including intravenous cabazitaxel every 21 days, oral abiraterone acetate with prednisone daily in 28-day cycles, oral enzalutamide daily in 28-day cycles, or lutetium Lu 177 vipivotide tetraxetan intravenously every 42 days for up to six cycles. Throughout treatment, patients have MRI, CT, and bone scans, with optional PET scans and blood collections. After treatment, patients without disease progression are followed every two months for six months, then every three months for up to five years those with progression are followed every six months for five years. Assessments include imaging, laboratory tests, and patient questionnaires to measure tumor response, progression, survival, symptomatic events, treatment tolerability, and quality of life. The trial monitors outcomes such as objective response within six months and longer-term survival up to five years.

Researchers are studying the effects of the medicine PF-08634404, given alone or with another antibody called ipilimumab, for treating advanced liver cancer known as hepatocellular carcinoma HCC that cannot be removed by surgery or has spread to other parts of the body. This is a clinical trial that includes adults aged 18 years or older who have locally advanced or metastatic HCC and have not received whole-body treatment for this cancer. Participants will be randomly assigned to receive either PF-08634404 alone or PF-08634404 combined with ipilimumab. Both medicines are given through intravenous IV infusions directly into a vein. The study involves sequential dose levels and will be conducted at clinical trial sites where medical staff will monitor participants during and after treatment visits. During the study, participants will be monitored for side effects and overall response to treatment. Researchers will evaluate safety, pharmacokinetics, and preliminary efficacy by measuring adverse events, dose-limiting toxicities, and tumor response using RECIST 1.1 criteria. Laboratory tests and immunological assessments will be performed up to approximately 24 months to understand how the medicines behave in the body and their effects on the cancer.